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Orthotics
Knee Brace Fastening Systems for Knee Osteoarthritis
N/A
Recruiting
Research Sponsored by TOPMED
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after 2 weeks of use for each arm
Awards & highlights
Study Summary
This trial tests how two different fastening systems for knee braces can affect comfort, ease of use, and treatment outcomes.
Who is the study for?
This trial is for individuals who have been using an ODRA knee brace for several hours daily over the past 6 months. It's aimed at those with osteoarthritis seeking better comfort and treatment outcomes from their braces. People with wounds on their lower body cannot participate.Check my eligibility
What is being tested?
The study is examining two different types of fastening systems for knee braces: one uses velcro straps, while the other employs a cable fastening mechanism. The goal is to compare how each system affects comfort, ease of use, and overall effectiveness in treating osteoarthritis symptoms.See study design
What are the potential side effects?
While not typical side effects as seen with medications, participants may experience discomfort or skin irritation from the different strap systems being tested. Psychological impacts due to ease of use or efficacy perceptions are also considered.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change between after 2 weeks adjustment period and after 2 weeks of use for each arm
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change between after 2 weeks adjustment period and after 2 weeks of use for each arm
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comfort
Physical symptoms
Psychological symptoms
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cable fastening systemExperimental Treatment1 Intervention
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a cable fastening system and 3d printed straps.
Group II: Velcro strapsActive Control1 Intervention
The knee brace is worn for 2 weeks after adjustment period. The knee brace is held in place by a velcro straps system.
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Who is running the clinical trial?
Conseil de recherches en sciences naturelles et en génie du CanadaUNKNOWN
2 Previous Clinical Trials
98 Total Patients Enrolled
TOPMEDLead Sponsor
7 Previous Clinical Trials
518 Total Patients Enrolled
Laboratoires VicthomUNKNOWN
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been wearing an ODRA knee brace for several hours per day over the past 6 months.You have wounds below your waist.
Research Study Groups:
This trial has the following groups:- Group 1: Velcro straps
- Group 2: Cable fastening system
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the cap for participants in this clinical experiment?
"That is accurate. According to clinicaltrials.gov, this research initiative posted on March 30th 2023 is presently recruiting participants. 10 people need to be enrolled at a single trial site for the study's completion."
Answered by AI
Is the enrollment period still active for this trial?
"The details hosted on clinicaltrials.gov demonstrate that this research is actively seeking participants. It was launched on March 30th 2023, and the latest update took place April 12th of the same year."
Answered by AI
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